Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.

Detailed Description

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Conditions

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Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever

Keywords

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Allergy Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ciclesonide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* General good health, other than perennial allergic rhinitis
* History and diagnosis of perennial allergic rhinitis by skin prick
* Normal body weight as defined by the study protocol

Exclusion Criteria

* Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period
* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the excipients in the formulations
* Use of any prohibited concomitant medications as defined by the study protocol
* Previous participation in an intranasal ciclesonide study
* Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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BY9010/M1-409

Identifier Type: -

Identifier Source: org_study_id